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EC number: 701-284-5 | CAS number: 2137881-70-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. Exceeds guideline study in that the effect of the pH value was clearly elucidated.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)
- GLP compliance:
- no
- Type of assay:
- Drosophila SLRL assay
Test material
- Reference substance name:
- Formic acid
- EC Number:
- 200-579-1
- EC Name:
- Formic acid
- Cas Number:
- 64-18-6
- Molecular formula:
- CH2O2
- IUPAC Name:
- formic acid
- Reference substance name:
- Sodium formate
- EC Number:
- 205-488-0
- EC Name:
- Sodium formate
- Cas Number:
- 141-53-7
- Molecular formula:
- CHO2Na
- IUPAC Name:
- sodium formate
- Details on test material:
- - Name of test materials (as cited in study report):
Formic acid
Sodium formate; produced by neutralization of 0.1% formic acid with glycine-NaOH buffer.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Name of test materials (as cited in study report):
Formic acid
Sodium formate; produced by neutralization of 0.1% formic acid with glycine-NaOH buffer.
Test animals
- Species:
- Drosophila melanogaster
- Strain:
- other: Oregon-K
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: feed was used to allow dosing of both the liquid acid and the solid sodium formate salt
- Duration of treatment / exposure:
- entire larval stage
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1% as formic acid
Basis:
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
Any other information on results incl. tables
RS-Freetext:
1) Vapor experiment
Exposure to 0.1% Formic Acid (FA) significantly (p<0.001) increased the
number of mutations compared to controls.
=========================================================
Brood
1st 2nd 3rd total
---------------------------------------------------------
n % n % n % n %
---------------------------------------------------------
FA 1068 1.12 1130 1.42 850 1.41 3048 1.31
Historical control 2584 0.15
=========================================================
n = number of chromosomes tested
% = percentage of sex-linked lethals found
2) Larval feeding experiments
Exposure to 0.1% Formic Acid (FA) increased the number of mutations
without gaining statistical significance between broods or compared to
controls.
===========================================================
Brood
1st 2nd 3rd total
-----------------------------------------------------------
n % n % n % n %
-----------------------------------------------------------
FA 786 1.15 522 1.34 671 0.88 1879 1.11
NaF 544 0.38
Historical control 2584 0.15
===========================================================
n = number of chromosomes tested
% = percentage of sex-linked lethals found
NaF = Formic acid, neutralized to pH = 7.5 using a 0.1 M glycine-NaOH buffer.
The sodium formate (NaF; produced from formic acid by neutralization)
sex-linked lethal was not different from the control.
Formic acid results of the feeding study were also stated as not being
significantly different from control.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
Formic acid was tested for genetic toxicity in a multigenerational test in Drosophila melanogaster similar to the OECD Guideline No. 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster). Following exposure to 0.1% formic acid vapour, the number of mutants was significantly increased compared to historical controls (p<0.001).
An increase was also seen with 0.1% formic acid in a subsequent feeding experiment, but without gaining statistical significance. Sodium formate (produced by neutralization of formic acid) at the same molar concentration in the feed was negative in the Drosophila SLRL test. The authors concluded that the mutations observed with formic acid were related to the acidic pH, rather than to the acid or the formate molecule itself.
Conclusion:
Formic acid and sodium formate did not induce mutations in the Drosophila SLRL test in vivo.
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